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Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer

This study has been completed.
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society Identifier:
First received: August 10, 2010
Last updated: March 6, 2014
Last verified: March 2014
The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.

Condition Intervention
Bladder Cancer
Device: White Light
Device: Narrow Band Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, International Study to Compare Use of Narrow Band Imaging (NBI) Versus White Light(WL) During Transurethral Resection of Bladder Tumors (TURB) to Asses Recurrence of Bladder Cancer in Terms of Safety and Efficacy

Resource links provided by NLM:

Further study details as provided by Clinical Research Office of the Endourological Society:

Primary Outcome Measures:
  • Recurrence rate at 1 year following Narrow Band Imaging and TURB (Arm A) versus White Light Trans Urethral Resection of Bladder cancer (TURB) (Arm B) in patients with non muscle invasive (pTa/T1) bladder cancer. [ Time Frame: At 3 months and 1 year after treatment ]

Secondary Outcome Measures:
  • Persistence/recurrence of tumors at first 3 month follow up after NBI versus WL cystoscopy and tumor resection. [ Time Frame: 3 months after treatment ]
  • Peri-operative morbidity (30 days) of TURB between NBI and WL resection using the Clavien system. [ Time Frame: 30 days ]
  • Risk factors for the development of peri-operative morbidity after instrumental treatment. [ Time Frame: 1 year ]
  • Recurrence rate related to surgeon performing the procedure. [ Time Frame: 1 year ]
  • Recurrence rate related to additional treatment following TURB. [ Time Frame: 1 year ]

Enrollment: 4
Study Start Date: August 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Narrow Band Imaging
Narrow Band Imaging (NBI)
Device: Narrow Band Imaging
Narrow Band Imaging
White Light Trans Urethral Resection
White Light Trans Urethral Resection
Device: White Light
White Light Cystoscopy

Detailed Description:
Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white light, or light that is generated encompassing the entire visual spectrum. Some tumors such as carcinoma in situ may not be visible using white light and require patients to undergo random bladder biopsies in order to find the cancer. Recently the development of photodynamic agents have been shown to enhance these procedures to accomplish better resection and identify over-looked tumors. However, these methods often require the instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band imaging (NBI) is now available which uses a special filter to limit the light to only certain wavelengths which allows the identification of areas of increased vascularity or abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal disease and found to be beneficial. Early reports in urology suggest that this technology may reduce the number of tumors that are missed which could impact the recurrence rate of bladder tumors, but this is not known at this time.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder cancer
  • Patients greater than 18 years of age
  • No tumors in the upper tract (kidneys or ureters)
  • No previous pelvic radiation

Exclusion Criteria:

  • Gross hematuria at the time of resection making visualization with NBI not possible
  • Participation in other clinical studies with investigations drugs concurrently or within 30 days.
  • Pregnancy
  • Conditions associated with a risk of poor compliance or unwilling to follow up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01180478

Sponsors and Collaborators
Clinical Research Office of the Endourological Society
Study Director: Jean de la Rosette, MD AMC University Hospital
  More Information

Responsible Party: Clinical Research Office of the Endourological Society Identifier: NCT01180478     History of Changes
Other Study ID Numbers: 10-004660
Study First Received: August 10, 2010
Last Updated: March 6, 2014

Keywords provided by Clinical Research Office of the Endourological Society:
Bladder Cancer
Urothelial carcinoma
Stage pTa or pT1
Narrow Band Imaging
White Light Cystoscopy
Transurethral resection
Superficial bladder tumor
Positive urine cytology

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on April 26, 2017